On November 26, 2021 Healthcare and Optellum reported that they have signed a letter of intent to collaborate to advance precision diagnosis and treatment of lung cancer. GE Healthcare is a global leader in medical imaging solutions. Optellum is the leader in AI decision support for the early diagnosis and optimal treatment of lung cancer (Press release, GE Healthcare, NOV 26, 2021, View Source [SID1234596113]).

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Together, the companies are seeking to address one of the largest challenges in the diagnosis of lung cancer, helping providers to determine the malignancy of a lung nodule: a suspicious lesion that may be benign or cancerous. The majority of incidentally detected pulmonary nodules present an indeterminate cancer risk, and are incredibly challenging for clinicians to diagnose and manage, leading to delayed treatment for cancer patients and invasive procedures on healthy people.

Optellum’s Virtual Nodule Clinic identifies and scores the probability of malignancy in a lung nodule, which is key to determining whether biopsy is necessary, and accelerating diagnosis. It is the only FDA-cleared AI-assisted diagnosis software for early-stage lung cancer1, and has been shown to improve the sensitivity and specificity of malignancy assessments of indeterminate nodules 2 — enabling pulmonologists and radiologists to make optimal clinical decisions3.

The clinician’s AI-assisted diagnosis of malignancy may enable patients whose nodules are not malignant to avoid unnecessary and aggressive procedures such as biopsy and surgical resection, while expediting the diagnostic process, and enabling the right treatment to start earlier. This has the potential to provide patients with personalized diagnosis and treatment plans, enabling lung cancer patients to be treated at the earliest possible stage when survival rates are the highest.

GE plans to collaborate with Optellum’s sales team on the distribution of the Virtual Nodule Clinic and work with Optellum to integrate the platform with AI solutions powered by GE Healthcare’s Edison platform. In addition the companies intend to bring results from Optellum’s Lung Cancer Prediction AI into the existing workflow of various GE Healthcare technological pathways, including CT and PACS.

"The precise diagnosis of lung cancer can greatly improve patient prognosis," said Ben Newton, General Manager, Oncology Solutions, at GE Healthcare. "The integration of imaging and medical device data from the Edison Platform with AI-enabled solutions like the one offered by the Optellum Virtual Nodule Clinic has the potential to streamline clinician workflows and advance our goal of making precision healthcare, taking the right action at the right time for every patient, at scale, as widely accessible as possible."

"This collaboration is a major step forward for Optellum and the field of thoracic oncology at large," commented Václav Potěšil, PhD, Founder and Chief Business Officer of Optellum. "GE’s vast clinical network can accelerate deployment of Optellum’s platform and could enable a revolutionary redefinition of early lung cancer treatment for clinicians and patients around the world."

On November 26, 2021 The Iceland based healthcare investor, Aztiq ("Aztiq"), founded by Alvogen’s Chairman and CEO, Róbert Wessman and Innobic Asia ("Innobic"), a wholly-owned Life Science arm of PTT Public Company Limited ("PTT", SET ticker: PTT), Thailand’s largest publicly traded conglomerate, reported that have signed a definitive agreement to acquire a 100% stake in Alvogen Emerging Market Holdings Limited ("AEMH") from Alvogen Lux Holdings Sarl ("Alvogen") (Press release, Lotus Pharmaceutical , NOV 26, 2021, View Source [SID1234596109]). Key shareholders in Alvogen include CVC Capital Partners ("CVC") and Temasek Holdings of Singapore ("Temasek"), as well as Aztiq. The total transaction value is estimated to be approximately US$475 million, and the deal is expected to close during the first quarter 2022.

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With this transaction the consortium becomes the leading shareholder in the global oncology pharmaceutical company Lotus Pharmaceuticals ("Lotus", TWSE ticker: 1795), and the owner of 100% shares in Alvogen Malta (Out-Licensing) Holding Ltd., shareholder of the fast-growing global business to business (B2B) pharmaceutical company Adalvo.

Alvogen Lux Holdings Sarl will remain a leading shareholder in the generics pharmaceutical company Alvogen US, including specialty pharma company Almatica, as well as being the second largest shareholder in global biosimilar company Alvotech.

Róbert Wessman, Chairman and CEO of Alvogen and Founder of Aztiq, will continue to serve as Chairman of the board of Lotus and Adalvo.

Róbert Wessman, Chairman and CEO of Alvogen/ Founder of Aztiq, commented: "I am very proud to have witnessed the maturation of both Lotus and Adalvo. I would like to take this opportunity to thank the existing shareholders for their great support in transformation and at the same time I would like to welcome our new partner as we look forward to carrying out the essential work of expanding access to medicines with strong expertise collectively by all parties. With the comprehensive geographic networks and solid market intelligence in ASEAN brought by PTT and Innobic, I believe that Lotus and Adalvo will have a compelling competitive advantage, which enables them to become global leaders in the pharma industry."

Tomas Ekman, Director of the Board, Alvogen Lux Holding Sarl commented: After seven years as the lead shareholder of Lotus and the broader Asian business, Alvogen concluded that now is the right time to monetize our investment and letting Aztiq and Innobic continue the journey Lotus is on. Both Adalvo and Lotus will continue to collaborate closely with the Alvogen group of companies. Today’s announcement is consistent with Alvogen’s strategic focus and we intend to deploy the proceeds from the transaction in line with our capital allocation priorities to maximize shareholder value.

Dr. Buranin Rattanasombat, Senior Executive Vice President, Innovation and New Ventures, PTT and Chairman of Innobic (Asia), commented: "This partnership will accelerate our goal and enable Innobic to leap into being a fully integrated pharmaceutical company. By being the major shareholder in Lotus jointly with Aztiq, Innobic will have access to the capability of operating a full suite of pharmaceutical business, ranging from research, development, and formulation to production and commercialization, with a primary focus on generic drugs covering a wide range of therapeutic areas, in particular, oncology and central nervous system. The strengthened access to high quality medicines, together with the global networks and commercialization capability of Adalvo, and Innobic’s support to further expand the pharmaceutical businesses in the ASEAN and globally, make this investment fully in line with the goals and strategies for realizing life science business in Thailand and the ASEAN."

Alvogen acquired a majority stake in Lotus in 2014 and together with its shareholders, Lotus has evolved into a next generation pharmaceuticals company focused on global oncology with direct market access in more than 10 countries in Asia and global reach of its portfolio to over 130 markets.

Alvogen has further developed Adalvo in 2018 from an in-house B2B platform into a separate business unit focusing on global markets. In a short period of time, Adalvo has achieved a remarkable growth with over 500 transactions and a world class portfolio of 60 differentiated medicines and is currently one of the fastest growing B2B pharmaceutical company globally, serving its partners and patients in over 100 markets around the world.

In April of 2021, Innobic invested approximately US$50 million into Lotus by acquiring newly-issued shares via a private placement. Both parties, Lotus and Innobic, are committed to further collaboration with the aim of expanding access to high quality medicines. Further participation by Innobic, through its investment in AEMH, demonstrates both a strong belief in the Lotus strategy as well as a commitment to drive opportunities in South East Asian pharmaceutical markets including Thailand, Vietnam, Philippines, Malaysia and other ASEAN countries.

On November 26, 2021 Oasmia Pharmaceutical’s CEO, Dr Francois Martelet reported that it will present at Aktiespararna’s Stora Aktiedagen Stockholm on December 2, 2021 (Press release, Oasmia, NOV 26, 2021, View Source [SID1234596108]). The presentation starts at 9:30 CET and will be broadcast live as a webcast at: www.aktiespararna.se/tv/live.

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The presentation will be available online the following day on www.aktiespararna.se/tv/evenemang and on Oasmia Pharmaceutical’s website www.oasmia.com.

On November 26, 2021 Oasmia Pharmaceutical’s CEO, Dr Francois Martelet reported that it will present at the Erik Penser BankLife Science Day on December 2, 2021 (Press release, Oasmia, NOV 26, 2021, View Source [SID1234596107]). The presentation starts at 13:45 CET and will be live streamed via View Source

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The presentation will be held in English and will also be available afterwards on Oasmia Pharmaceutical’s website www.oasmia.com

On November 26, 2021 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported financial results for the quarter ended September 30, 2021 (Press release, Can-Fite BioPharma, NOV 26, 2021, View Source [SID1234596106]).

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Corporate and Clinical Development Highlights Include:

Completed Patient Enrollment in Phase III Psoriasis Study – The Phase III Comfort study completed patient enrollment. Topline results are expected in Q1 2022. The study is designed to establish Piclidenoson’s superiority compared to placebo and non-inferiority compared to Apremilast (Otezla) in patients with moderate to severe plaque psoriasis.

Can-Fite Ends Phase II COVID-19 Trial to Focus on Core Indications – In 2020, with the aim of developing a much-needed drug to treat manifestations of COVID-19, mainly the Cytokine Release Syndrome, Can-Fite initiated a Phase II COVID-19 study of its lead drug candidate, Piclidenoson, with patient enrollment in Israel and Europe. With the anticipated launch of Pfizer’s oral COVID-19 antiviral drug candidate, Can-Fite has made a strategic decision to end its COVID-19 program and to focus its resources on its other clinical programs, all in advanced clinical trials.

Patents Granted for NASH in Japan, Hong Kong, and Mexico – Can-Fite continues to build its IP portfolio for NASH which now includes patents granted and allowed in 37 countries. Most recently, patents were issued and allowed in Japan, Hong Kong, and Mexico for the patent titled "An A3 Adenosine Receptor Ligand for Use In Treating Ectopic Fat Accumulation". This patent addresses the use of the A3 Adenosine Receptor (A3AR) ligand, the target receptor for Can-Fite’s drug platform technology, in the treatment of NASH.

Data on A3AR-based Cannabis Compounds in the Treatment of Liver Diseases Presented at AASLD and Published in HEPATOLOGY – Can-Fite delivered a poster presentation titled "Growth Inhibition of Hepatocellular Carcinoma (HCC) by CBD Rich T3/C15 Cannabis Fraction is Mediated via the A3 Adenosine Receptor" at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting during the Hepatobiliary Neoplasia: Experimental Hepatocarcinogenesis; Diagnostics and Liver Imaging session. The findings were also published in an abstract in the October 2021 supplement of HEPATOLOGY, a premier peer-reviewed publication in the field of liver disease published on behalf of the AASLD.

Positive Phase IIa NASH Data Published in Alimentary Pharmacology & Therapeutics – The peer-reviewed scientific journal focused on gastroenterology and hepatology published an article titled "Randomised clinical trial: A phase 2 double-blind study of namodenoson in non-alcoholic fatty liver disease and steatohepatitis". The article includes highlights from Can-Fite’s Phase IIa NASH study of Namodenoson which achieved its study endpoints including significant anti-steatotic, anti-fibrotic, and anti-inflammatory effects.

Fortified Balance Sheet

On September 30, 2021, Can-Fite had approximately $13.3 million in cash, cash equivalents, and short-term deposits.

"Our NASH program has received a high level of interest at scientific conferences based on our positive Phase IIa results, and we continue to fortify our IP around this indication. We expect to commence enrollment in our pivotal Phase III liver cancer and Phase IIb NASH studies, as we look forward to topline results from our Phase III in psoriasis in the first quarter of 2022. Our advanced pipeline with a growing body of safety and efficacy data has significant potential to help patients with unmet needs," stated Can-Fite CEO Dr. Pnina Fishman.

Financial Results

Revenues for the nine months ended September 30, 2021 were $0.65 million compared to revenues of $0.61 million during the nine months ended September 30, 2020. The increase is considered immaterial.

Research and development expenses for the nine months ended September 30, 2021 were $6.75 million compared with $9.06 million for the same period in 2020. Research and development expenses for the nine months period ended September 30, 2021 comprised primarily of expenses associated with two studies for Piclidenoson, a Phase II study in COVID-19 and a Phase III study in the treatment of psoriasis. The decrease is primarily due to costs incurred in the first nine months of 2020 associated with Phase II studies for Namodenoson in the treatment of liver cancer and NASH, and a Phase III study of Piclidenoson for the treatment of rheumatoid arthritis, partially offset by the two ongoing studies of Piclidenoson in the first nine months of 2021. We expect research and development expenses will increase for the remainder of 2021 and beyond.

General and administrative expenses were $2.71 million for the nine months ended September 30, 2021 compared to $2.14 million for the same period in 2020. The increase is primarily due to the increase in salaries and related benefits due to the distribution of bonuses to employees, increase in public relations expenses and insurance expenses. We expect general and administrative expenses will remain at the same level for the remainder of 2021 and beyond.

Financial income, net for the nine months ended September 30, 2021 was $0.31 million compared to financial expense, net of $0.22 million for the same period in 2020. The decrease in financial expense, net was mainly due to finance income recorded from revaluation of our short-term investments.

Can-Fite’s net loss for the nine months ended September 30, 2021 was $8.49 million compared with a net loss of $10.81 million for the same period in 2020. The decrease in net loss was primarily attributable to a decrease in research and development expenses which were partly offset by an increase in general and administrative expenses and a decrease in finance expenses, net.

As of September 30, 2021, Can-Fite had cash, cash equivalents and short-term deposits of $13.3 million as compared to $8.26 million at December 31, 2020. The increase in cash during the nine months ended September 30, 2021 is due to an aggregate of $2.74 million in net proceeds received through warrant exercise transactions during the first quarter of 2021, an advance payment of $2.25 million from a distribution agreement with Ewopharma and from a $10 million registered direct offering in August 2021 which were offset by Company’s operating activity.

The Company’s consolidated financial results for the nine months ended September 30, 2021 are presented in accordance with US GAAP Reporting Standards.